Institute of Good Manufacturing Practices India®

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NeuroGenesis declares positive data from multiple sclerosis trial

NeuroGenesis Bio's interim analysis of a Phase II clinical trial extension for NG-01 in progressive MS yielded promising results. NG-01, the company's lead candidate, is an autologous bone marrow-derived stem cell therapy designed to enhance remyelination and neurotrophic factor secretion at CNS injury sites.

The double-blind study aims to evaluate NG-01's long-term impact on serum biomarkers, physical/cognitive functions, and patient-reported outcomes in progressive MS. Initial allocation divided 48 participants into groups receiving NG-01 or a placebo via intrathecal or intravenous injections. During the extension, patients received one to three intrathecal NG-01 injections at intervals of three to six months.

Analysis of 23 patients, receiving at least two NG-01 treatments, showed significant reductions in neurofilament-light chains (NfL) and glial fibrillary acidic protein (GFAP), indicative of reduced neurodegeneration and inflammation. Improvements in walking ability were observed in 16 patients after 12 months. No severe adverse events were reported, with minor side effects like headache and backache.